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Program Extension of Real Life Dosing of Remicade in Austria for Crohn's Disease (Study P04052)(COMPLETED)

This study has been completed.
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00724958
First received: July 25, 2008
Last updated: October 1, 2015
Last verified: October 2015
Results First Received: July 13, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Crohn's Disease
Intervention: Biological: Infliximab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Remicade Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.

Participant Flow:   Overall Study
    Remicade
STARTED   348 
COMPLETED   166 
NOT COMPLETED   182 
Adverse Event                28 
Loss of Response                40 
No Response                18 
Remission                7 
Other Reason                76 
No documentation for end of therapy                13 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Remicade Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting who received at least one infliximab infusion.

Baseline Measures
   Remicade 
Overall Participants Analyzed 
[Units: Participants]
 343 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.68  (12.30) 
Gender 
[Units: Participants]
 
Female   178 
Male   165 
Region of Enrollment 
[Units: Participants]
 
Austria   343 


  Outcome Measures
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1.  Primary:   Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)   [ Time Frame: up to 2 years ]

2.  Primary:   Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)   [ Time Frame: up to 2 years ]

3.  Primary:   Average Dose of Infliximab Per Participant Within the Observation Period   [ Time Frame: up to 2 years ]

4.  Primary:   Median Dose of Infliximab Per Participant Within the Observation Period   [ Time Frame: up to 2 years ]

5.  Primary:   Total Dose of Infliximab Per Participant Within the Observation Period   [ Time Frame: up to 2 years ]

6.  Secondary:   Assessment of the Disease Activity Before Treatment and During Therapy With Remicade Via Harvey Bradshaw Index (HBI) in an Extended Patient Group of 200 Patients.   [ Time Frame: 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
e-mail: ClinicalTrialDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00724958     History of Changes
Other Study ID Numbers: P04052
Study First Received: July 25, 2008
Results First Received: July 13, 2011
Last Updated: October 1, 2015
Health Authority: Austria: No HA submission required